(6 days)
Not Found
No
The summary lacks any mention of AI, ML, image processing, or performance studies typically associated with AI/ML-powered devices. The predicate device is also a non-AI system.
No
The intended use explicitly states "diagnosis and monitoring of dental caries," which are diagnostic functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" states "For use by dental professionals as an aid in the diagnosis and monitoring of dental caries." This explicitly indicates a diagnostic purpose.
Unknown
The provided 510(k) summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components. The predicate device (K090598 CarieScan PRO System) is a hardware-based device, suggesting the new device might also have hardware, but this is not explicitly stated.
Based on the provided information, this device is likely not an IVD.
Here's why:
- Intended Use: The intended use is "as an aid in the diagnosis and monitoring of dental caries." While diagnosis is mentioned, the key factor for IVD classification is that the diagnostic information is derived from in vitro examination of specimens from the human body.
- Device Description: The description is "Not Found," so we can't see if it involves analyzing biological samples.
- Mentions image processing, AI, DNN, or ML: These are "Not Found," which doesn't directly rule out IVD, but many modern IVDs involve these technologies for analyzing biological data.
- Input Imaging Modality: "Not Found" again, which doesn't suggest the analysis of biological samples.
- Anatomical Site: "dental" is the anatomical site. While some dental procedures involve collecting samples (like saliva or tissue), the description doesn't indicate this is the case.
- Predicate Device: The predicate device is the "CarieScan PRO System (K090598)". Looking up this predicate device would be the most definitive way to confirm its classification. However, based on the name and the intended use, it's likely a device that directly interacts with the tooth (e.g., using electrical impedance or optical methods) rather than analyzing a biological sample.
In summary, the provided information strongly suggests the device is used to directly assess the tooth structure for caries, rather than analyzing a biological sample taken from the patient. This aligns with a non-IVD classification.
To be absolutely certain, you would need to examine the full regulatory submission for this device and the predicate device (K090598) to understand the specific technology and how it interacts with the patient. However, based on the provided text, it does not appear to meet the criteria for an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.
Product codes
NBL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Nikola Skelly Head of Quality & Regulatory Affairs CarieScan Limited Unit 5 Gateway West. Luna Place, Technology Park Dundee, Angus UNITED KINGDOM DD2 1XZ
MAY 1 7 2011
Re: K11321
Trade/Device Name: CarieScan PRO Regulation Number: 21 CFR 872:1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: May 6, 2011 Received: May 11, 2011
Dear Ms. Skelly:
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. 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.
1
Page 2 - Ms. Skelly
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
ph. for
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Special 510(k): K090598 CarieScan PRO System Modification
06 May 2011
INDICATIONS FOR USE 4
510(k) Number (if known):
KIII331 、・・・
Device Name:
CarieScan PRO
Indications For Use:
For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.
Prescription Use
/
Over The Counter Use AND/OR
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pumpe
siology, General Hosnits
page 8 of 227
CarieScan Ltd