(293 days)
Not Found
No
The description focuses on a light source and fiber optic guide for enhanced visualization, with no mention of AI/ML, image processing, or data analysis.
No
The device aids in visualization for diagnosis but does not treat the oral lesions.
Yes
Explanation: The device is described as an "aid to improve the visualization of oral lesions" and is "used to enhance dental examination of lesions," which points to its use in identifying or characterizing a medical condition, making it a diagnostic device.
No
The device description explicitly states it consists of a battery-powered light source and a fiber optic light guide, which are hardware components.
Based on the provided information, this device 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.
- Device Function: The description clearly states that this device is used to improve the visualization of oral lesions during a traditional examination. It's a tool to enhance the visual inspection of the oral mucosa.
- Mechanism: The device uses light and a rinse to make lesions more visible. It does not analyze a sample taken from the body.
- Classification: The device is described as a "non-tissue contacting" device and a "510(k) Exempt FDA Device." This classification is consistent with a device used for examination and visualization, not for in vitro testing.
Therefore, the Microlux/DL is a diagnostic aid used for visual examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Microlux/DL is used as an aid to improve visualization of oral lesions. This device is used as an aid to improve the visualization of oral lesions. It is designed to be used by a dentist or health care provider, in combination with a traditional examination by incandescent light.
Product codes
EAZ
Device Description
The Microlux/DL is used to enhance dental examination of lesions of the oral mucosa. The device consists of a battery powered light source that uses a blue-white LED, a rigid diffused fiber optic light guide. It is used in conjunction with a non-toxic dilute (1%) acetic acid rinse for the viewing of oral lesions. The fiber optic illuminator itself is non-tissue contacting, and is classified as a 510(k) Exempt FDA Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist or health care provider
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
§ 872.4630 Dental operating light.
(a)
Identification. A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
APR - 4 2005
REVISED 510(k) SUMMARY
| Submitters Name: | Joshua Friedman, D.D.S | Date of Submission: March 28, 2005 |
|---|---|---|
| Address: | AdDent, Inc. | |
| 43 Miry Brook Rd. | ||
| Danbury, CT 06810 | Contact Person: Joshua Friedman | |
| Phone: | (203) 778-0200 | E-mail: jfriedman@addent.com |
| Fax: | (203) 792-2275 | |
| Device Name: | Microlux/DL | |
| Common Name: | Intra Oral Examination Light | |
| Classification Name: | Light, Fiber Optic, Dental |
Marketed Device of Equivalence: Visilite
Description of Device:
The Microlux/DL is used to enhance dental examination of lesions of the oral mucosa. The device consists of a battery powered light source that uses a blue-white LED, a rigid diffused fiber optic light guide. It is used in conjunction with a non-toxic dilute (1%) acetic acid rinse for the viewing of oral lesions. The fiber optic illuminator itself is non-tissue contacting, and is classified as a 510(k) Exempt FDA Device.
Intended Use: The Microlux/DL is used as an aid to improve visualization of oral lesions.
Characteristics of Microlux/DL Compared to Predicate Device:
The Microlux DL compares favorably and is substantially equivalent to another legally marketed device. The Microlux DL functions in a manner similar to and is used for the same purpose as the Speculite/OraLite manufactured by Trylon Corp. It is also sold under the name Visilite™ by Zila, Inc. The 510K number of the predicate device is K012070 and K003995.
The OraLite uses a chemical luminescent light source that produces a diffused blue-white light. The Microlux DL uses a blue-white LED and a diffused fiber optic light guide to provide a diffused blue-white light. The LED in the Microlux/DL has a color temperature of 6500°K and nominal chromaticity coordinates of X= .31 and Y =.32.
The OraLite uses a 1% acetic acid mouth rinse prior to examination. The Microlux DL uses a 1% acetic acid mouth rinse prior to examination.
Essentially, the only difference between the Microlux DL and the predicate device is that the Microlux DL uses a Blue-White LED as a light source and the Visilite uses a Blue-White chemical luminescent light source. The associated 1% acetic rinse and diagnostic procedure are identical.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal lines above it, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 4 2005
Joshua Friedman, DDS President AdDent, Incorporated 43 Miry Brook Road Danbury, Connecticut 06810
Re: K041614
Trade/Device Name: Microlux/DL Regulation Number: 21 CFR 872.4630 Regulation Name: Dental Operating Light Regulatory Class: I Product Code: EAZ Dated: February 3, 2005 Received: February 7, 2005
Dear Dr. Frieman:
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.
2
Page 2 - Dr. Frieman
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.
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
3
INDICATIONS FOR USE
510(k) Number (if known): K041614
Device Name: Microlux/DL
Indications for Use:
This device is used as an aid to improve the visualization of oral lesions. It is designed to be used by a dentist or health care provider, in combination with a traditional examination by incandescent light.
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) (Division Sign-Oif) Olvision of Anesthesiology, General Hospital, Page 1 of 1 Infection Control, Dental Devices 510(k) Number