(88 days)
Not Found
Not Found
No
The provided text does not contain any mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is used to help identify caries in dentin, which is a diagnostic function, not a therapeutic one. It assists in diagnosis rather than providing treatment.
Yes
The device is described as a "Caries Indicator" designed to "help identify caries in dentin," which directly indicates its use in diagnosing a medical condition.
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 (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "help identify caries in dentin." This describes a diagnostic aid used in vivo (on a living patient) during a dental examination.
- Anatomical Site: The anatomical site is "dentin," which is part of the tooth structure within a living patient.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens outside the body (in vitro), such as blood, urine, tissue samples, etc., to diagnose diseases or conditions. The description doesn't mention any such specimen analysis.
While the device is used for diagnostic purposes, the method described (identifying caries in dentin) points towards an in vivo diagnostic tool used directly on the patient, rather than an in vitro diagnostic device that analyzes samples in a lab setting.
N/A
Intended Use / Indications for Use
Caries Indicator is indicated for the following applications: Designed to be used to help identify caries in dentin.
Product codes
LFC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
dentin
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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, representing health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2003
Mr. Stephen Rudolph Quality Manager Confi-Dental Products Company 416 South Taylor Avenue Louisville, Colorado 80027
Re: K030807
Trade/Device Name: Caries Indicator Regulation Number: 872.1740 Regulation Name: Caries Detection Device Regulatory Class: II Product Code: LFC Dated: March 10, 2003 Received: March 13, 2003
Dear Mr. Rudolph:
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 Federal Register.
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Page 2 - Mr. Rudolph
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ver/ 3 - 4/24/96
Applicant: Confi-Dental Products Company
510% number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Device Name: Caries Indicator
Indications for Use:
Caries Indicator is indicated for the following applications:
Designed to be used to help identify caries in dentin.
(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
Ke Muly Samsa
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K030807
(Optional Format 1-2-96)