C50
Device Facts
| Record ID | K223470 |
|---|---|
| Device Name | C50 |
| Applicant | Sopro |
| Product Code | NBL · Dental |
| Decision Date | Dec 14, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.1745 |
| Device Class | Class 2 |
Indications for Use
C50 is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to magnification).
Device Story
C50 is an intraoral video camera used by dental practitioners to visualize oral structures and assist in diagnosis. The device uses LEDs to illuminate the inspection site and a CMOS sensor to capture natural fluorescence or standard images. It operates in four modes: CARIO (blue mode) for highlighting potential caries in pits and fissures; DAYLIGHT (white mode) for general visualization; DAYLIGHT+ (white mode) for high-contrast visualization; and PERIO (yellow mode) for highlighting dental plaque and gingival inflammation. Images are converted to a video signal and transmitted via USB to a computer for display. The practitioner uses the screen output to identify clinical conditions, monitor dental hygiene, and show patients 'before' and 'after' care results. The device aids in clinical decision-making by providing magnified views and fluorescence-based detection of pathology. It is intended for use in a clinical dental setting.
Clinical Evidence
Bench testing only. Evidence includes comparative image quality testing (sharpness, resolution, focus), mechanical performance testing of tips and protective sheaths, electrical safety and EMC testing (IEC 60601-1, IEC 60601-1-2, IEC/TR 60601-4-2), photobiological safety (IEC 62471), software validation (IEC 62304), and biocompatibility testing (ISO 10993-1) including cytotoxicity and acute systemic toxicity. All acceptance criteria were met.
Technological Characteristics
Intraoral camera with LED illumination and CMOS sensor. Features four modes: CARIO, DAYLIGHT, DAYLIGHT+, and PERIO. Provides Full HD (1920 x 1080) resolution. Connectivity via USB Type-C to USB-A. Includes automatic or single focus. Materials evaluated per ISO 10993-1. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 62471 (photobiological).
Indications for Use
Indicated for general dentistry patients as an aid in diagnosing pit and fissure caries, highlighting dental plaque, and identifying gingival inflammations that lead to bleeding upon probing; also used as an intra-oral camera for visualizing anatomical details.
Regulatory Classification
Identification
A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.
Special Controls
*Classification.* Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter; (2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and (3) The labeling must include detailed use instructions with precautions that urge users to: (i) Read and understand all directions before using the device, (ii) Store probe tips under proper conditions, (iii) Properly sterilize the emitter-detector handpick before each use, and (iv) Properly maintain and handle the instrument in the specified manner and condition.
1. restrictions on the sale, distribution, and use of the device to prescription use in accordance with 21 CFR 801.109; 2. clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and 3. labeling that includes detailed use instructions with precautions that urge users to (i) read and understand all directions before using the device, (ii) store probe tips under proper conditions, (iii) properly sterilize the emitter-detector handpiece before each use, and (iv) properly maintain and handle the instrument in the specified manner and condition.
Predicate Devices
- SOPROCARE (K121685)
Submission Summary (Full Text)
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December 14, 2023
SOPRO Kim Rouahi Regulatory Affairs & Quality Director Zac Athelia IV Avenue Des Genevriers La Ciotat, Bouches-Du-Rhone 13705 FRANCE
Re: K223470
Trade/Device Name: C50 Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NBL Dated: December 1, 2023 Received: December 1, 2023
Dear Kim Rouahi:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
# Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices 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) K223470
Device Name C50
Indications for Use (Describe)
C50 is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to magnification).
Type of Use (Select one or both, as applicable)
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| <div> <span> <svg height="1em" width="1em"><path d="M12.736 3.97a.733.733 0 0 0-1.047 0c-.286.289-.754.759-1.979 1.977-.216.215-.437.439-.753.754c-.285.285-.753.754-1.046 0a.716.716 0 0 0 0-1.048c.287-.285.754-.755 1.047 0c.319.318.541.548.758.757c1.223 1.22 1.686 1.689 1.977 1.977c.287.285.754.755 1.047 0a.733.733 0 0 0 0 1.047c-.286.289-.754.759-1.979 1.977-.216.215-.437.439-.753.754c-.285.285-.753.754-1.046 0a.716.716 0 0 0 0-1.048c.287-.285.754-.755 1.047 0c.319.318.541.548.758.757c1.223 1.22 1.686 1.689 1.977 1.977c.287.285.754.755 1.047 0a.733.733 0 0 0-1.047-1.047c-.286.289-.754.759-1.979-1.977-.216-.215-.437-.439-.753-.754c-.285-.285-.753-.754-1.046 0a.716.716 0 0 0 0 1.048c.287.285.754.755 1.047 0c.319-.318.541-.548.758-.757c1.223-1.22 1.686-1.689 1.977-1.977c.287-.285.754-.755 1.047 0a.733.733 0 0 0 0-1.047z" fill="currentColor"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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## 510(K) Summary - K223470
Date: December 11, 2023
| Submitter: | SOPRO |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name: | ZAC Athélia IV - Avenue des Genévriers 13705 LA |
| Address: | CIOTAT Cedex |
| Contact Person: | Kim ROUAHI |
| | +33667690060 |
| Product: | C50 |
| Name of Device: | Intraoral Camera |
| Common Name: | II |
| Regulatory Class: | 21 CFR 872.1745 - Laser, Fluorescence Caries Detection |
| Classification: | NBL |
| Product Codes: | |
| Predicate Device: | K121685 SOPROCARE |
| Device Description: | The C50 is an intraoral video camera equipped with LEDs to illuminate the inspection site. The C50 optics and its complementary metal oxide semiconductor (CMOS) sensor capture the natural fluorescence of the site under observation and convert the images into a video signal that is sent to the computer via a USB interface. The dental practitioner can use the images displayed on the computer screen as an aid in diagnosis. A USB Type-C (camera) to USB-A cable is provided to connect the C50 to a computer. The C50 provides the following functions: Aid in the detection of pit and fissure caries Information about patient dental hygiene Highlighting of dental plaque Highlighting of gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) Showing the difference between "before" and "after" care (follow-up). In CARIO mode (blue mode), the camera assists the dental practitioner by highlighting potential carious areas in pits and fissures on the occlusal surface of the teeth. In DAYLIGHT mode (white mode), the camera enables visualization of anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). DAYLIGHT+ mode (white mode) is a shortcut version of DAYLIGHT mode where the contrast has been pushed from 20 to 70. In PERIO mode (yellow mode), the camera helps the dental practitioner to visualize dental plaque, in addition to highlighting areas of gingival inflammation (restricted to gingival inflammation that leads to bleeding upon probing). |
| Indications for Use: | C50 is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to magnification). |
| Technological Characteristics: | Subject and predicate devices are both manufactured by SOPRO. Predicate and subject device technological and performance characteristics are fundamentally the same, as shown by the following table. The subject device includes a device modification to add an additional mode, DAYLIGHT+ mode. |
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| | Predicate Device | Modified Device/ Subject<br>Device | Discussion |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SOPRO | SOPRO | - |
| Product Name | SOPROCARE | C50 | - |
| Common Name | Intraoral camera | Intraoral camera | - |
| Classification<br>Regulation | 21 CFR 872.1745<br>21 CFR 872.1740 | 21 CFR 872.1745 | - |
| 510(k) Number | K121685 | K223470 | - |
| Indications for Use | SOPROCARE is intended for<br>clinical practice of general<br>dentistry, as an aid in the<br>diagnosis of pit and fissure<br>caries, as an aid to highlight<br>dental plaque and gingival<br>inflammations (restricted to<br>gingival inflammations which<br>lead to bleeding upon probing)<br>and as intra-oral camera to<br>visualize anatomical details<br>invisible to the naked eye or<br>with a mirror (thanks to its<br>magnification). | C50 is intended for clinical<br>practice of general dentistry,<br>as an aid in the diagnosis of pit<br>and fissure caries, as an aid to<br>highlight dental plaque and gingival inflammations<br>(restricted to gingival<br>inflammations which lead to<br>bleeding upon probing) and as<br>intra-oral camera to visualize<br>anatomical details invisible to<br>the naked eye or with a mirror<br>(thanks to its magnification). | Same |
| DEVICE DESIGN AND<br>USE | | | |
| Design | Image: SOPROCARE design | Image: C50 design | -- |
| Operational Modes | • CARIO<br>• DAYLIGHT<br>• PERIO | • CARIO<br>• DAYLIGHT<br>• PERIO<br>• DAYLIGHT+ | The new DAYLIGHT+<br>mode is similar to<br>DAYLIGHT mode. It<br>offers a higher-<br>contrast image. The<br>remaining modes<br>are identical. |
| Focus | 4 pre-set positions | Automatic focus or Single<br>focus | The modified device<br>includes automatic<br>focus. The focus<br>range is similar for<br>both<br>devices. |
| Technology | Fluorescence technology | Fluorescence technology | Same |
| System of Image<br>Capture | Image capture button on<br>handpiece | Image capture button on<br>handpiece | Same |
| Accessories | • Intraoral tip<br>• Dedicated protective sheath<br>• Handpiece holder<br>• USB cable | • Intraoral tip<br>• Protective sheath (third<br>party)<br>• Handpiece holder<br>• USB cable | The C50 intraoral<br>camera is intended<br>for use with legally<br>marketed protective<br>sheaths cleared by<br>FDA as a barrier<br>sleeve for intraoral<br>cameras. |
| User interface | 2 button keyboard for mode<br>selection | 5 button keyboard for mode<br>selection and on-screen<br>display control | Similar |
| Power Supply | Docking station | USB | Different |
| IMAGING | | | |
| | Predicate Device | Modified Device | Discussion |
| Light Source | LED | LED | Same |
| Returned Light | Standard image and<br>fluorescence | Standard image and<br>fluorescence | Same |
| Lens | Multiple lens system with<br>optical glass | Multiple lens system with<br>optical glass | Same |
| Sensor Resolution | NTSC | Full HD 1920 x 1080 | Different |
| PHYSICAL<br>CHARACTERISTICS | | | |
| Dimensions | L = 200mm x W = 28mm x H =<br>24mm | L = 200mm x W = 30mm x H =<br>24mm | Similar |
| Weight | 100g | 78 g | Similar |
| Cable Length | 3 m | 2.5m | Similar |
| Working<br>temperature | +10 °C / +40 °C | +10 °C / +35 °C | Similar |
| Working relative<br>humidity | 10% to 90% | 10% to 90% | Same |
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Discussion: The modified C50 intraoral camera is very similar to the predicate device SOPROCARE in terms of design, size and weight specifications. Patient contacting materials of the modified and predicate devices are identical in formulation, manufacturing process, processing and geometry.
> The On-Screen Display (OSD) of the C50 allows the device to be used with other imaging software (OIS), including Twain or Sopro SDK integration.
> The subject device C50 offers Full HD resolution instead of the predicate NTSC resolution, thus enhancing image quality. The C50 is connected to a computer by means of a USB cable.
> The C50 intraoral camera is intended for use with legally marketed protective sheaths cleared by FDA as a barrier sleeve for intraoral cameras (product code PEM).
Performance Design verification and validation testing to support determination of substantial equivalence Testing: consisted of the following tests:
- Comparison testing of image quality, sharpness, size, resolution, focus position and potential elevation in the temperature target tissue have been performed using the C50 and the third-party protective sheath and the accessory C50TIPS and have been shown to be substantially equivalent to the predicate device.
- Mechanical performance testing was performed on reprocessed C50TIPS to ensure that the device maintains its position on the C50 camera and completely blocks all external light.
- Mechanical testing was performed with regard to fit of the third-party protective sheath with the C50 and the accessory C50TIPS.
- . Electrical safety testing & EMC
Electrical (IEC 60601-1 and collateral standards) and EMC testing were conducted on the C50 device, consistent with the appropriate sections of the following current standards:
- o IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2 "Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
- o IEC/TR 60601-4-2 Medical Electrical Equipment Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- Photobiological safety testing was conducted on the C50 device, consistent with the appropriate section of the following current standard: IEC 62471 Photobiological safety of lamps and lamp systems.
- Software validation was performed on the C50's firmware consistent with the appropriate section of the following current standard: IEC 62304 Software life cycle process.
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- . Reprocessing validation testing was conducted on the C50, C50TIPS and USB cable in accordance with the recommendations outlined in FDA Guidance Document: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- . Biocompatibility testing
The patient contact materials of C50TIPS were evaluated in accordance with the requirements of international standard ISO 10993-1 (Biological Evaluation of Medical Devices) and FDA Guidance Document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process". The following biocompatibility tests were considered:
> Chemical caracterization Cytotoxicity Acute Systemic Toxicity
Acceptance criteria were met for all tests performed.
- The subject device C50 and its accessories have the same intended use and similar Conclusion: technological characteristics as the predicate device SOPROCARE and the associated accessories. The information provided in this 510(k) submission indicates that the C50 intraoral camera and its accessories (intraoral tip, handpiece holder and USB cable) are substantially equivalent to the predicate device.
