(44 days)
Curing of dental composites using visible light.
Doctor's Light LED Dental Curing Light is a hand-held polymerization light intended for use in curing dental composites. This product uses a rechargeable Li-ion Battery for cordless operation.
The provided text is a 510(k) summary for a dental curing light, which is a physical device, not an AI/ML algorithm. Therefore, many of the requested categories for AI/ML device studies, such as sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment, are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1) | Meets standard |
| Electromagnetic Compatibility (IEC 60601-1-2) | Meets standard |
| Performance Specifications | Bench testing demonstrated compliance |
| Equivalence to Predicate Devices: | |
| - Light source | Equivalent to predicate devices |
| - Power source | Equivalent to predicate devices |
| - Wavelength | Equivalent to predicate devices |
| - Materials | Equivalent to predicate devices |
| - Light intensity | Equivalent to predicate devices |
| - Peak wavelength | Equivalent to predicate devices |
| - Depth of cure | Equivalent to predicate devices |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device and submission. The performance was assessed through bench testing and comparison to predicate devices, not through a data-driven test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth establishment with experts is relevant for diagnostic or AI/ML devices, not for a dental curing light whose performance is determined by physical characteristics and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a standalone physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" equivalent for this device type would be the established scientific and engineering principles for dental curing lights, as well as the specifications of the predicate devices. Performance was verified against these benchmarks and relevant industry standards (IEC 60601-1, IEC 60601-1-2).
8. The sample size for the training set
Not applicable. There is no training set for a dental curing light.
9. How the ground truth for the training set was established
Not applicable.
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Submitter Information: Emergo Group Inc. 1705 S Capital of Texas Hwy Suite 500 Austin, TX 78746
AUG 2 3 2007
Date Summary Prepared: July 9, 2007
Contact Persons: Ian P Gordon igordon@emergogroup.com
Device Name:
Trade Name(s): Doctor's Light LED Dental Curing Light Classification Name: Ultraviolet Activator for Polymerization Panel: Dental Product Code: EBZ
Predicate Device Information:
Bluephase® marketed by Ivclar Vivodent, Incoporated, under K033520; and Turbo-Pen marketed by Apoza Enterprize Co., Ltd.
Device Description:
Doctor's Light LED Dental Curing Light is a hand-held polymerization light intended for use in curing dental composites. This product uses a rechargeable Li-ion Battery for cordless operation.
Intended Use:
This device is intended for curing dental composites using visible light.
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in intended use and technological characteristics, including:
- Light source .
- Power source .
- Wavelength .
- Materials .
- Light intensity .
- Peak wavelength .
- Depth of cure .
Performance Test Data and Conclusions:
This device meets consensus standards IEC 60601-1 for electrical safety and IEC 60601-1-2. Bench testing was also conducted to demonstrate performance specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 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" written around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines that suggest the bird's head, body, and tail. The logo is black and white.
AUG 2 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Good Doctors Company, Limited C/O Mr. Ian P. Gordon Senior Vice President Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin. Texas 78746
Re: K071908
Trade/Device Name: Doctor's Light LED Dental Curing Light Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: July 05, 2007 Received: July 10, 2007
Dear Mr. Gordon:
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. Gordon
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 yours.
Sudite Y. Michael Ours
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
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Indications for Use
510(k) Number (if known):
Device Name: Doctor's Light LED Dental Curing Light
Indications for Use:
Curing of dental composites using visible light.
Prescription Use XX (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Marley for MSR
Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
(10(k) Nur
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.