(23 days)
R-Sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.
The R-Sensor dental sensor is intended to replace film and to capture an intraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes.
The subject R-Sensor is an intraoral digital x-ray system comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Management Software package.
The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².
R-Sensor, Size 1 is also known as factory code S11684-12; R-Sensor, Size 2 is also known as factory code S116845-12.
The provided text describes the "R-Sensor," an intraoral digital x-ray sensor, and its substantial equivalence to a predicate device, the "QuickRay HD." The document primarily focuses on demonstrating that the R-Sensor is identical to the predicate device, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the R-Sensor itself.
Therefore, the information below is derived from the comparison to the predicate and the general statements about the device's characteristics, as the document states the two devices are identical in all aspects.
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission argues for substantial equivalence based on the R-Sensor being identical to the predicate device (QuickRay HD), the "acceptance criteria" are implicitly met by matching the predicate's specifications and performance where specified. The document does not explicitly state unique acceptance criteria for the R-Sensor but rather focuses on demonstrating its identical characteristics to the cleared predicate.
| Characteristic | Acceptance Criteria (Implied from Predicate & Standards) | Reported Device Performance (R-Sensor) |
|---|---|---|
| Resolution | Real ≥ 20 lp/mm (from predicate) | Real ≥ 20 lp/mm |
| Pixel size | 20 x 20μm (from predicate) | 20 x 20μm |
| Grey levels | 14 bits (from predicate) | 14 bits |
| Lifespan CMOS | Min. 100,000 cycles (from predicate) | Min. 100,000 cycles |
| Electrical Safety | Conforms to IEC 60601-1 | Conforms to IEC 60601-1 |
| EMC | Conforms to IEC 60601-1-2 | Conforms to IEC 60601-1-2 |
| Image Quality / DQE | Conforms to IEC 62220-1 | Bench tests performed in conformance with IEC 62220-1 |
| Ingress Protection (IP Code) | Conforms to IEC 60529 | Bench tests performed in conformance with IEC 60529 |
| Biocompatibility | No direct/indirect patient-contacting components (addressed by single-use barrier) | Biocompatible testing not warranted due to single-use protective barrier. |
| Diagnostic Relevance | Images diagnostically relevant and reliable (based on clinical images of the "complete system" - likely the predicate or very similar system) | Clinical images found to be diagnostically relevant and reliable. |
2. Sample size used for the test set and the data provenance
The document mentions "Clinical images were provided" for the R-Sensor to demonstrate that "the complete system works as intended." However, it explicitly states these images "were not necessary to establish substantial equivalence based on the modifications to the predicate device but they provide further evidence in addition to bench testing data." This suggests the primary "test set" for equivalence relies on the established performance of the predicate device and bench testing of the R-Sensor's components.
- Sample size for clinical images: Not specified.
- Data provenance: Not specified, but a qualified practitioner in Ormond Beach, FL reviewed them. It's unclear if these were retrospective or prospective, or from what country of origin beyond the U.S. location of the reviewing practitioner.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: One expert is explicitly mentioned.
- Qualifications of experts: Dr. Parham, a "qualified practitioner in Ormond Beach, FL." Specific specialty (e.g., dentist, radiologist) or years of experience are not provided.
4. Adjudication method for the test set
Not applicable/Not specified. The clinical images were "examined by Dr. Parham" and "found to be diagnostically relevant and reliable," suggesting a single-reader assessment rather than an adjudication process involving multiple experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This document does not mention an MRMC comparative effectiveness study or any AI component. The R-Sensor is described as a hardware device (intraoral sensor) with associated image management software, performing as a receiver of X-rays to capture images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance assessment of the R-Sensor hardware was performed through bench testing conforming to IEC 62220-1 (for DQE, influencing image quality) and other standards (IEC 60601-1, IEC 60601-1-2, IEC 60529). The "algorithm" here refers to firmware and driver, which are part of the sensor's electronics, and image management software. The entire system's performance, including software, is presented as being identical to the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "clinical images" section, the ground truth was established by the assessment of a single "qualified practitioner" who deemed them "diagnostically relevant and reliable." For the direct comparison, the "ground truth" for substantial equivalence is the previously cleared predicate device, QuickRay HD, and its established performance and adherence to standards.
8. The sample size for the training set
Not applicable. The document describes a medical device seeking 510(k) clearance based on substantial equivalence to an existing predicate. It does not describe an AI/ML device that requires a training set. The firmware and drivers were provided by Hamamatsu, and the image management software (Xray Vision) is an off-the-shelf package cleared previously (K983111).
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 2020
Remedi Co. Ltd. % W. Lee Strong Quality Systems Manager 510K FDA. Inc. 100 E Granada Blvd, Suite 219 ORMOND BEACH FL 32176
Re: K200284
Trade/Device Name: R-Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: January 23, 2020 Received: February 5, 2020
Dear W. Lee Strong:
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
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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Indications for Use
510(k) Number (if known) K200284
Device Name R-Sensor
Indications for Use (Describe)
R-Sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral 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 a stylized black and white drawing of an eagle's head and wing. The eagle's head is facing to the right, and its wing is raised upward. The wing has several distinct feathers, and the overall design is sleek and modern.
510k FDA Consulting
Medical Device Clearance
100 East Granada Blvd., Suite 219
Ormond Beach, FL 32176
386-506-8711
510 (k) Summary
Submitter/Applicant
Remedi Co. Ltd. #1409, IS BIZ Tower, 26 Yangpyeong-ro 21-gil Yeongdeungpo-gu, Seoul, Korea Phone: +82-2-6968-2041 Fax,: +82-2-6968-2042
Primary Contact: Aaron Min kyungwook.min@remedihc.com Secondary Contact: Jadon Koo, PhD, CEO, Jadon Koo jadon.koo@remedihc.com
Date Prepared: January 31, 2020
Preparer/Consultant
510K FDA, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176
Phone: 386-506-8711 Fax: 386-672-4402
Primary Contact: Lee Strong, Quality Systems Manager, lee@510kfda.com Secondary Contacts: Claude Berthoin, President (claude@510kfda.com).
Device Classification
| Trade Name: | R-Sensor |
|---|---|
| Common Name: | Intraoral Digital X-Ray Sensor |
| Regulation Number: | 21 CFR 872.1800 |
| Classification Name: | Extraoral Source X-Ray System |
| Product Code: | MUH |
| Submission Type: | 510(k) |
| Regulatory Class: | 2 |
| Medical Specialty: | Dental |
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FDA Guidance
The following guidance documents were utilized in the development of this device:
- l. Guidance for the Submission of 510(k)'s for Solid State Imaging Devices
-
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
-
- Postmarket Management of Cybersecurity in Medical Devices
- Pediatric Information for X-ray Imaging Device Premarket Notifications 4.
- Guidance for Industry and FDA on Alternative to Certain Prescription Device Labeling 5. Requirements
-
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
Predicate Device
The following predicate is a legally marketed, post-amendment device:
| 510(k) Number: | K151926 |
|---|---|
| Clearance Date: | December 14, 2015 |
| Actual Trade Name: | QuickRay HD |
| Regulation & PC: | 872.1800; MUH |
K151926 is identical to the subject device.
Device Description
The subject R-Sensor is an intraoral digital x-ray system comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Management Software package.
The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².
R-Sensor, Size 1 is also known as factory code S11684-12; R-Sensor, Size 2 is also known as factory code $116845-12.
Before Remedi sells this device, our technicians discuss the hardware and software that the dentist has, to make sure that their systems are compatible with the R-Sensor. Remedi offers technical support for this device to ensure proper operation and to answer any questions regarding the function of the device. A means to contact Remedi is provided to all end users and in our user manual.
The type of x-ray systems that integrate with the R-Sensor are wall-mounted x-ray generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time.
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This device and software cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver.
X-ray Vision, software by Apteryx (K983111) cleared on November 16, 1998, is supported on Windows XP, Vista, 7, 8, 8.1 and 10. Absolute minimum requirements for PC hardware for the sensor and software combination would be a Pentium 4 or better processor. At least 1 GB of RAM. 200MB of hard drive space for the software, plus additional space for the user database (recommended 40GB minimum), a USB 2.0 or 3.0 and a 100MB wired Ethernet connection is needed if networked.
The Xray Vision software by Apteryx is a Windows based image management database/software primarily used by dentists to acquire, enhance, store, communicate, print, recall and display digital images.
The firmware in the R-Sensor has already been cleared. The subject device is the exact same device as the QuickRay HD sensor, K151926. The subject device is identical in firmware/hardware from Hamamatsu, and the software is identical from Apteryx. Hamamatsu is the main subcontractor of this device for Remedi International, Inc.
The QuickRay HD device also has 2 sizes like our subject device. The subject device and the QuickRay HD device are identical in all aspects of the device. They will have different names only for marketing purposes and that does not change the safety and effectiveness of the subject device.
The latest publication of CR Clinicians the November newsletter reports that 70% of all the practices use dental sensors and only 16% use film. This newsletter may be reviewed in section 21 _Other.
Indications for Use
R-Sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
Intended Use
Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.
The R-Sensor dental sensor is intended to replace film and to capture an intraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes.
Comparison of Technological Characteristics with Predicate
The subject R-Sensor and predicate QuickRay HD are identical devices.
Both are comprised of the following two components...
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- Intraoral Detector System... The subject device and predicate device include an . intraoral detector, flexible cord, and direct USB 2.0 plug, as described in subject R-Sensor and predicate QuickRay HD marketing literature in this petition.
- . Imaging Software... Both the subject and predicate use a third party software called Xray Vision which is manufactured by Apteryx in Akron, Ohio (K983111) cleared November 16, 1998.
| Comparison Table | R-SensorK200284 | QuickRay HD | Differences |
|---|---|---|---|
| 510(k) | Not assigned yet | K151926 | NA |
| Applicant/Assembler/Repackager/Relabeler | Remedi Co, Ltd.(Ormond Beach, FL) | Denterprise Intl, Inc.(Ormond Beach, FL) | NA |
| Manufacturer-Imaging SWComponent | Apteryx (Akron, OH) | Apteryx (Akron, OH) | Same |
| Classification & Product Code | 872.1800; MUH | 872.1800; MUH | Same |
| Common name | Intraoral Digital X-RaySensor | Intraoral Digital X-RaySensor | Same |
| Intended use | Radiographicexamination to assistwith diagnosis ofdiseases of the teeth,jaw, and oral structure. | Radiographicexamination to assistwith diagnosis ofdiseases of the teeth,jaw, and oral structure. | Same |
| Principles of operation | X-ray (radiation) =>scintillator (convert tolight) => fiber optic(filtering) => CMOS(convert to digital) =>electronics => PC(capture & display image) | X-ray (radiation) =>scintillator (convert tolight) => fiber optic(filtering) => CMOS(convert to digital) =>electronics => PC(capture & display image) | Same |
| Software-Firmware | Firmware combined onsensor electronic board | Firmware combined onsensor electronic board | Same |
| Software—Image Management | Xray Vision (OTS packagefrom Apteryx, USA) | Xray Vision (OTS packagefrom Apteryx, USA) | Same |
| Sensor technology | CMOS chip + optical fiberplate + CSi scintillator | CMOS chip + optical fiberplate + CSi scintillator | Same |
| Matrix dimensions (mm2) | Active area: 600mm²(Size 1) 884mm² (Size 2) | Active area: 600mm²(Size 1) 884mm² (Size 2) | Same |
| Comparison Table | R-SensorK200284 | QuickRay HD | Differences |
| Matrix dimensions (pixels) | 1000 lines X 1500columns (Size 1); 1300 X1700 (Size 2). | 1000 lines X 1500columns (Size 1); 1300 X1700 (Size 2). | Same |
| Lifespan CMOS | Min. 100,000 cycles | Min. 100,000 cycles | Same |
| Resolution | Real ≥ 20pl/mm | Real ≥ 20pl/mm | Same |
| Pixel size | 20 X 20μm | 20 X 20μm | Same |
| Grey levels | 14 bits | 14 bits | Same |
| Sensor board | All control electronicsdirectly integrated onCMOS sensor chip | All control electronicsdirectly integrated onCMOS sensor chip | Same |
| Sensor shell | Specific shape design;material is ABS and theflammability is HB if YK-94 (UL File No. 49895) | Specific shape design;material is ABS and theflammability is HB if YK-94 (UL File No. 49895) | Same |
| Cable material and design | Cable consists of PVC,ETFE, copper, plugconnector and sensorconnector, diameter ф3.7±0.3 and cable length 2meters. | Cable consists of PVC,ETFE, copper, plugconnector and sensorconnector, diameter ф3.7±0.3 and cable length 2meters. | Same |
| Connection to imaging practicePC | USB 2.0 High-Speed | USB 2.0 High-Speed | Same |
| Operating temperature | 0°C to 35°C | 0°C to 35°C | Same |
| Sensor input voltage and current | 5V (via USB connection);0.15A Max | 5V (via USB connection);0.15A Max | Same |
| Standards of conformity | IEC 60601-1 (Electrical);IEC 60601-1-2 (EMC)62220-1 (Performance)60529 (IP Code) | IEC 60601-1 (Electrical);IEC 60601-1-2 (EMC)62220-1 (Performance)60529 (IP Code) | Same |
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Input Calculation software*1 Output
Image /page/8/Figure/1 description: The image contains two plots showing the relationship between spatial frequency and MTF (Modulation Transfer Function) and NNPS (Normalized Noise Power Spectrum). The first plot shows MTF decreasing as spatial frequency increases, starting at 1.0 at 0 cycles/mm and decreasing to nearly 0 at 25 cycles/mm. The second plot shows NNPS decreasing as spatial frequency increases, starting at approximately 1.E-06 mm² at 0 cycles/mm and decreasing to approximately 1.E-07 mm² at 25 cycles/mm.
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Performance Data
Clinical images were examined by Dr. Parham, a qualified practitioner in Ormond Beach, FL and found to be diagnostically relevant and reliable.
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the predicate device but they provide further evidence in addition to bench testing data to show that the complete system works as intended.
Biocompatibility
Biocompatible testing for the subject is not warranted because there are no direct or indirect patient-contacting components in the subject device. It is covered with a single-use protective barrier prior to each use just like the QuickRay HD predicate.
Electrical Safety and EMC
EMC and electrical safety testing data reports for the subject device are provided in this petition.
- The R-Sensor conforms to electrical and safety standard IEC 60601-1 (Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance).
- . The R-Sensor conforms to electrical and safety standard IEC 60601-1-2 (Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential 3271performance - collateral standard: Electromagnetic compatibility).
Software Verification and Validation Testing
R-Sensor electronics contains firmware along with a driver both provided by Hamamatsu. Additionally, R-Sensor uses image management software provided by Apteryx Company; therefore, only firmware and driver documentation for the subject device are included in this petition.
Bench Testing
Bench tests were performed in conformance with IEC 62220-1 (Medical Electrical Equipment - Characteristics of Digital X-ray Imaging Devices-Part 1: Determination of the Detective Quantum Efficiency and IEC 60529 (Degrees of Protection Provided by Enclosures—IP Codes).
Conclusions
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The subject and the predicate device have the same intended use, same design, and the same technological features. R-Sensor and QuickRay HD share the same principles of operation, sensor technology, use the same USB connection to PC and use the same imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate.
The sensors will only have different brand names for marketing purposes. Therefore, R-Sensor warrants a finding of substantial equivalence to the QuickRay HD and thus clearance for premarket activities in the United States.
§ 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.