(566 days)
No
The description focuses on different light sources for imaging and integration with existing dental imaging software, with no mention of AI or ML for image analysis or diagnosis.
No
The device is described as an aid in "detection and diagnosis" of dental caries, which aligns with diagnostic rather than therapeutic use. It uses imaging to identify issues but does not provide treatment.
Yes
The device's "Intended Use / Indications for Use" explicitly states it is "intended to be used as an aid in the detection and diagnosis of dental caries."
No
The device description clearly states it is a "toothbrush-sized handpiece" with a camera, LED lights (white, fluoresced, infrared), and connects via a USB cable. This indicates significant hardware components beyond just software.
Based on the provided information, the IC-WHCD100 (Inspire) is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The IC-WHCD100 directly examines the tooth surface in situ (inside the mouth). It does not analyze samples like blood, urine, tissue, or other bodily fluids or substances that have been removed from the body.
- The device description clearly states it's a "toothbrush-sized handpiece" positioned "over the tooth to be examined." This indicates direct interaction with the patient's tooth, not the analysis of a collected specimen.
- The imaging modalities (White LED, Fluoresced light, Infrared light) are used to illuminate and capture images of the tooth surface. This is a form of in vivo imaging, not in vitro analysis.
Therefore, the IC-WHCD100 falls under the category of a medical device used for imaging and diagnosis in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The IC-WHCD100 (Inspire) is intended to be used as an aid in the detection and diagnosis of dental caries.
Product codes
NBL
Device Description
The IC-WHCD100 is a toothbrush-sized handpiece used for diagnosis of caries. A USB cable is used to connect the handpiece to a personal computer with a dental imaging software.
After a camera cover is placed over the end, the handpiece is positioned over the tooth to be examined. The camera takes images by illuminating the tooth surface with a white LED light for regular tooth image. With fluoresced light, the device can show bacteria on the surface of tooth. With infrared light, the device can show tooth cavity by highlighting enamel. The user can view the images on 510k cleared dental imaging software such as Apteryx Vision (K983111), Romexis (K171385), Sidexis (K132773), etc.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
White LED light, fluoresced light, infrared light
Anatomical Site
Tooth surface / inside of the mouth or oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Test for imaging (Image Sharpness, Image Size, Image Resolution, tooth ● Caries Detection)
- EMC and Electrical Safety Testing in accordance with IEC 60601-1 & IEC 60601-1-2 ●
- Software Validation Test
- Biocompatibility Tests (Cytotoxicity, Irritation, and Skin Sensitization) in accordance ● with ISO 10993-5 and ISO 10993-10.
- Cleaning and Disinfecting Validation Test by referencing ISO 10993-17, AAMI TIR12, AAMI TIR30, ASTM E2314-03, ISO 15883-1, ISO 15883-5, ISO 10993-12, ISO/TS 17665-2
- Optical Radiotin Safety Test in accordance with IEC 62471 .
The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K172007, K983111, K171385, K132773, K143290
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1745 Laser fluorescence caries detection device.
(a)
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.(b)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 2, 2020
Good Doctors Co.,Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt. Ste 200 Irvine, California 92620
Re: K183471
Trade/Device Name: IC-WHCD100 (Inspire) Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NBL Dated: June 8, 2020 Received: June 9, 2020
Dear Priscilla Chung:
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.
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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 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 Srinivas ''Nandu'' Nandkumar, Ph.D. Director DHT1B: Division of Dental 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)
Device Name
IC-WHCD100 (Inspire)
Indications for Use (Describe)
The IC-WHCD100 (Inspire) is intended to be used as an aid in the detection and diagnosis of dental caries.
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
(K183471)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 2, 2020
1. 510K Applicant / Submitter:
Good Doctors Co., Ltd. #208, Woolim Lions Valley B-dong, 283 Bupyeong-daero, Bupyeong-gu, Incheon 403-911, Republic of Korea Tel: +82-32-424-6325 Fax: +82-32-424-6326
2. Submission Contact Person
LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Proprietary Name: IC-WHCD100 (Inspire) .
- Common Name: Intraoral camera with Caries Detection Aid ●
- Classification: Class II (21 CFR 872.1745) .
- Product Code: NBL .
4. Predicate Devices
-
Primary Predicate: VistaCam iX Proof (K150672)
-
Reference Device: CamX Triton HD Proxi Head (K172007). XRAY VISION (K983111). Planmeca Romexis (K171385), SIDEXIS 4 (K132773), DBSWIN And VistaEasy Imaging Software (K143290)
5. Description:
The IC-WHCD100 is a toothbrush-sized handpiece used for diagnosis of caries. A USB cable is used to connect the handpiece to a personal computer with a dental imaging software.
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After a camera cover is placed over the end, the handpiece is positioned over the tooth to be examined. The camera takes images by illuminating the tooth surface with a white LED light for regular tooth image. With fluoresced light, the device can show bacteria on the surface of tooth. With infrared light, the device can show tooth cavity by highlighting enamel. The user can view the images on 510k cleared dental imaging software such as Apteryx vision (K983111), Romexis (K171385), Sidexis (K132773), etc.
8. Indications for Use
The IC-WHCD100 (Inspire) is intended to be used as an aid in the detection and diagnosis of dental caries.
9. Substantial Equivalence Discussion:
The subject device has the same indications for use as the predicate devices. The power supply and lighting source are also the same.
The predicate device. VistaCam IX Proof, shows fluorescence image using 405nm light source and the reference device, CamX Triton HD Proxi Head, shows transillumination image using 840nm (infrared) light source. The subject device, IC-WHCD100, uses 405nm and 940nm (infrared), and offers both modes(fluorescence & transillumination) that VistaCam IX Proof and CamX Triton HD Proxi Head each offers.
The subject device uses 940nm. whereas, the reference device uses 840mm, however, the performance test results of the subject device supports that the transillumination mode works well despite this difference. The lens type and the resolutions are also different but again the performance test result supports that the subject device is substantially equivalent to the predicate devices.
| Applicant device | Primary device | Reference Device | ||
|---|---|---|---|---|
| Company | Good Doctors Co., Ltd. | Durr Dental AG | Durr Dental AG | |
| Product name | IC-WHCD100(inspire) | VistaCam IX Proof | CamX Triton HD Proxi | |
| Head | ||||
| Common | ||||
| name | Intraoral camera | Intraoral camera | Intraoral camera | |
| Classification | ||||
| Regulation | 21 CFR 872.1745 | |||
| Laser Fluorescence Caries | ||||
| Detection Device | 21 CFR 872.1745 | |||
| Laser Fluorescence | ||||
| Caries Detection Device | 21 CFR 872.1745 | |||
| Laser Fluorescence | ||||
| Caries Detection | ||||
| Device | ||||
| Classification | ||||
| name on FDA | Laser, Fluorescence Caries | |||
| Detection | Laser, Fluorescence | |||
| Caries Detection | Laser, Fluorescence | |||
| Caries Detection | ||||
| 510(k) | ||||
| Number | K183471 | K150672 | K172007 | |
| Similarities | ||||
| Indication for | This device is an intraoral camera | The VistaCam iX | The CamX Triton HD | |
| use | used to take images of the inside of the mouth or oral cavity. | "Proof" is intended to be used as an aid in the detection and diagnosis of dental caries. | Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions | |
| Technology | Transillumination and fluorescence technology to aid in the detection of carious lesions | Fluorescence technology to aid in the detection of carious lesions | Transillumination to aid in the detection of carious lesions | |
| Detection wave length | 940nm, 405nm | 405 nm | 840 nm | |
| Power supply | USB 5V | USB 5V | USB 5V | |
| Lighting source | LED | LED | LED | |
| Sensor type | CMOS / 5M | CMOS | CMOS | |
| Resolution | 1280 x 720 | 1280 x 1024 | 1280 x 1024 | |
| Cable length | Approximately 3 meters | 2.5 meters | 2.5 meters | |
| Operating environment | 10-40 C | |||
| 20 to 80% RH non-condensing | 10-40 C | |||
| 20 to 75% RH non-condensing | 10-40 C | |||
| 20 to 75% RH non-condensing | ||||
| Appearance | Image: dental imaging device | Image: dental imaging device | Image: dental imaging device | |
| Differences | ||||
| Software | Can be use with other imaging software. | VistaCam iX "Proof" driver | ||
| software and DBSWIN. | ||||
| VistaCam iX "Proof" can only be used with DBSWIN imaging software | ||||
| Hand piece | Metal (Zinc + plating + UV | ASA+PC (Acrylonitrile | ASA+PC (Acrylonitrile | |
| housing | coating) | Styrene | ||
| Acrylate + | ||||
| Polycarbonate) | Styrene | |||
| Acrylate + | ||||
| Polycarbonate) | ||||
| Spacers | 8 mm | 8 mm | 8 mm | |
| Intensity | 3mW/cm squared at 8mm | 3 mW/cm squared at | ||
| 8mm | 4.1 mW / cm² at a | |||
| distance | ||||
| of 7 mm | ||||
| Lens | Liquid lens | 2 Duerr Dental lenses | 2 Duerr Dental lenses | |
| Size / weight | 129 x 21.5 x 32mm/ | |||
| 61g (without cable) | 7.48 x 1.03 x 1.03 | |||
| inches / | 7.48 x 1.03 x 1.03 | |||
| inches / |
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10. Performance Tests (Non-clinical)
- Performance Test for imaging (Image Sharpness, Image Size, Image Resolution, tooth ● Caries Detection)
- EMC and Electrical Safety Testing in accordance with IEC 60601-1 & IEC 60601-1-2 ●
- Software Validation Test
- Biocompatibility Tests (Cytotoxicity, Irritation, and Skin Sensitization) in accordance ● with ISO 10993-5 and ISO 10993-10.
- Cleaning and Disinfecting Validation Test by referencing ISO 10993-17, AAMI TIR12, AAMI TIR30, ASTM E2314-03, ISO 15883-1, ISO 15883-5, ISO 10993-12, ISO/TS 17665-2
- Optical Radiotin Safety Test in accordance with IEC 62471 .
The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.
11. Conclusions:
Based on the information provided in this premarket notification, Good Doctors Co., Ltd. concludes that the IC-WHCD100 (Inspire) is substantially equivalent to the predicate device as described herein in.