(57 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, deep learning, or any related concepts, and lacks information typically associated with AI/ML device submissions (training/test sets, performance metrics like AUC).
No
The device is a visual aid for identification, which is a diagnostic function, not a therapeutic one as it does not treat or cure a condition.
Yes
The device is described as a "visual aid for the identification of infected carious dentine," which directly implies its use in diagnosing a medical condition (infected carious dentine).
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, it is unlikely that this device is an IVD. Here's why:
- Intended Use: The intended use is "A visual aid for the identification of infected carious dentine." This describes a tool used in vivo (on a living patient) to help a healthcare professional visually assess a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Using reagents or assays.
- Providing quantitative or qualitative measurements of analytes.
In summary, the device appears to be a visual aid for direct observation of dentine in a patient, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
A visual aid for the identification of infected carious dentine.
Product codes
LFC
Device Description
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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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1740 Caries detection device.
(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its head and wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 7 2006
Ms. Annette Ravn Nielsen Export Manger RONVIG Dental Mfg. A/S Gl. Vejlevej 59 DK-8721 Daugaard DENMARK
Re: K060330
Trade/Device Name: SEE-IT™ Caries Detector Regulation Number: 872.1740 Regulation Name: Caries Detection Device Regulatory Class: II Product Code: LFC Dated: February 7, 2006 Received: February 9, 2006
Dear Ms. Nielsen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Eedera! Register.
1
Page 2 - Ms. Nielsen
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
yznette Y. Michine Cons
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name:
:
SEE-IT™ Caries Detector
INDICATIONS FOR USE
A visual aid for the identification of infected carious dentine.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Susan Dunne
v, General H
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use __ __ __ __
.
(Optional Format 1-2-96)
Exhibit 7