(207 days)
No
The summary does not mention AI, ML, or any related terms, and the device description is purely hardware-focused.
No.
The device is indicated as an aid in detection and diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that the system is "indicated as an aid in the detection and diagnosis of dental caries." The "Device Description" also says it "aids in the diagnosis of caries."
No
The device description explicitly states it consists of a handpiece and an umbilical cord connecting it to a computer and imaging software, indicating hardware components are part of the system.
Based on the provided information, the Spectra Fluorescence Caries Detection Aid System 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.
- Spectra System Function: The Spectra system uses fluorescence to examine the condition of a tooth directly in the mouth. It does not analyze samples taken from the body.
- Anatomical Site: The anatomical site is listed as "Dental," which refers to the teeth themselves, not a bodily fluid or tissue sample.
Therefore, the Spectra Fluorescence Caries Detection Aid System is a medical device used for in vivo (within the living body) examination, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Spectra Fluorescence Caries Detection Aid System is indicated as an aid in the detection and diagnosis of dental caries.
Product codes
NBL
Device Description
The Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental
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
Clinical testing was performed and established the effectiveness of the device to its claims.
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
Air Techniques, Inc. 1295 Walt Whitman Road, Melville, NY 11747
510(k)# K090169
EXHIBIT #6
510(K) SUMMARY
1. Submitted By:
Natalya Valerio Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747 Tel: (516) 433-7676
AUG 1 8 2009
Date Submitted: 08/05/09
2. Device Names:
Trade/Proprietary Name: Spectra Fluorescence Caries Detection Aid System
Common Name: Spectra Caries Detection Aid
Classification: Class II, 21 CFR 872.1745
Product Code: NBL
3. Predicate Device Information:
Inspektor Pro 510(k)# K040063 Inspector Dental Care, Amsterdam, Netherlands
4. Device Description:
The Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.
5. Indications for Use:
The Spectra Fluorescence Caries Detection Aid System is indicated as an aid in the detection and diagnosis of dental caries.
1
Air Techniques, Inc. 1295 Walt Whitman Road, Melville, NY 11747
510(k)# K090169
6. Discussion of Clinical Tests Performed:
Clinical testing was performed and established the effectiveness of the device to its claims.
Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:
The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to the predicate devices already in commercial distribution.
8. Conclusions:
Based on the same intended use and similar technological characteristics, Spectra Fluorescence Caries Detection Aid System is substantially equivalent to its predicate device Inspektor Pro cleared under 510(k) # K040063.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 1 8 2009
Air Techniques, Incorporated Ms. Natalya Valerio Official Correspondent MDI Consulting, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K090169
Trade/Device Name: Spectra Fluorescence Caries Detection Aid System Regulation Number: 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: August 5, 2009 Received: August 6, 2009
Dear Ms. Valerio:
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 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- Ms. Valerio
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,
Susan Penner
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infusion Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K090169
EXHIBIT #5
Indications for Use
Page . of । ー
510(k) Number (if known): K090169
Device Name: Spectra Fluorescence Caries Detection Aid System
Indications For Use:
Spectra Fluorescence Caries Detection Aid System is indicated as an aid in the detection and diagnosis of dental caries.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pearson
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K09169