(143 days)
Not Found
No
The description focuses on the physical instrument and software that quantifies fluorescence, without mentioning AI/ML algorithms for image analysis or diagnosis.
No
The device is used as an aid in diagnosis, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended to be used as an aid in the diagnosis of dental caries."
No
The device description explicitly states it consists of a "handheld instrument" that interfaces with software, indicating a hardware component is integral to the device's function.
Based on the provided information, the FluoreCam™ is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- FluoreCam™ Function: The FluoreCam™ directly examines the surface of a tooth in situ (within the body) using light and fluorescence. It does not analyze a sample taken from the body.
- Intended Use: The intended use clearly states it's an "aid in the diagnosis of dental caries," which is a condition of the tooth itself, not a systemic condition diagnosed through bodily fluids or tissues.
Therefore, the FluoreCam™ falls under the category of a medical device used for direct examination of a body part, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FluoreCam™ is intended to be used as an aid in the diagnosis of dental caries.
The FluoreCam™ is indicated as an aid in the diagnosis of dental caries.
Product codes
NBL
Device Description
The FluoreCam™ consists of a handheld instrument that interfaces with custom computer software via a USB connection. The instrument excites the surface of a tooth with light and transmits images of the surface to the software. The software quantifies carious activity using the auto fluorescent property of tooth enamel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth enamel
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
Safety and performance testing included comparison testing using polarized light microscopy as a gold standard, software/hardware hazard analysis, software verification and validation, and electromagnetic compatibility testing.
Key Metrics
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
APR 2 8 2010
Therametric Technologies, Inc.
351 West Tenth Street • Suite 222 • Indianapolis, Indiana 46202
510(K) SUMMARY
Applicant
George K. Stookey, Ph.D. President Therametric Technologies, Inc. 351 W. 10th St., Ste. 222 Indianapolis, IN 46202 Ph: 317/278-7876
Contact
Bart D. Collins Director of Dental Instruments Therametric Technologies, Inc. 351 W. 10th St., Ste. 222 Indianapolis, IN 46202 bcollins@therametric.com Ph: 317/278-7847 Fax: 317/278-7880
Date of Application
November 27, 2009
Applicant Device
Trade Name: Common Name: Classification: Classification Name: FluoreCam™ Fluorescence caries detection device Class II Fluorescence caries detection laser (21 CFR 872.1745, Product Code NBL)
Predicate Device
| Name: | Inspektor™ Pro |
|---|---|
| 510(k) Number: | K040063 |
Device Description
The FluoreCam™ consists of a handheld instrument that interfaces with custom computer software via a USB connection. The instrument excites the surface of a tooth with light and transmits images of the surface to the software. The software quantifies carious activity using the auto fluorescent property of tooth enamel.
1
Intended Use
The FluoreCam™ is intended to be used as an aid in the diagnosis of dental caries.
Substantial Equivalence
The FluoreCam™ is substantially equivalent to other legally marketed devices in the United States. The FluoreCam™ functions in a manner similar to and is intended for the same use as the Inspektor™ Pro designed by Inspektor Dental Care.
| FluoreCam™ | Inspektor™ Pro | |
|---|---|---|
| Intended Use | As an aid in the | |
| detection of dental | ||
| caries | As an aid in the | |
| detection of dental | ||
| caries | ||
| Device Type | Fluorescence caries | |
| detection device | Fluorescence caries | |
| detection device | ||
| Packaging | Single Use | |
| Disposable | Single Use | |
| Disposable | ||
| Patient-contacting | ||
| Material | Polypropylene | Polypropylene |
| Light Source | Light-emitting Diode | Xenon Lamp |
| Light Wavelength | Peak 405nm | Peak 405nm |
| Image Sensor | 1/4-inch CCD | 1/4-inch CCD |
Performance and Safety
Safety and performance testing included comparison testing using polarized light microscopy as a gold standard, software/hardware hazard analysis, software verification and validation, and electromagnetic compatibility testing.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
APR 2 3 2010
Mr. Bart Collins Director of Dental Instruments Therametric Technologies, Incorporated 351 West 10th Street, Suite 222 Indianapolis, Indiana 46202-4119
Re: K093705
Trade/Device Name: FluoreCam™ Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: April 13, 2010 Received: April 20, 2010
Dear Mr. Collins:
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.
3
Page 2- Mr. Collins
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 (OS) 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,
the 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 .
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K09370S
Indications for Use
510(k) Number (if known): ________
Device Name: FluoreCam™
Indications for Use:
The FluoreCam™ is indicated as an aid in the diagnosis of dental caries.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
C. Lee
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: K093705