(69 days)
BriteWhite Teeth Whitening System is intended to emit light in the 400 nanometer spectrum to provide a light source for the bleaching of teeth.
The BriteWhite Teeth Whitening System device that utilizes Light Emitting Diodes to provide a tooth whitening system, the whitening light source is a mouth piece which is placed inside the mouth, using barrier sleeves, which emits a biologically safe and effective level of blue visible light. The general wavelength for the mouth piece is 400 nanometer spectrums to provide a selected wavelength which activates the whitening gel to bleach the teeth without the aide of heat. To ensure user safety when operating the light, the system has a built in feature to eliminate any risk for the end user and professional. The light automatically shuts off after a specified period of time. Secondly, the light source in placed inside the mouth, so there is no need for safety glasses for the patient and professional. No contact with the eyes is in this area of treatment and prevents penetrations of blue wavelength and protects the vision of the patient and professional.
The provided text is related to a 510(k) submission for the BriteWhite Teeth Whitening System. This document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with specific acceptance criteria and performance data in the format of a clinical trial or performance study.
Therefore, many of the requested elements regarding acceptance criteria, study design, sample size, expert ground truth, and comparative effectiveness are not available in this type of regulatory document.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific, quantifiable acceptance criteria (e.g., a certain percentage improvement in tooth shade) or comparative performance data (e.g., measured whitening effectiveness). The clearance is based on substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Biologically safe level of light emission. | "biologically safe and effective level of blue visible light" |
| Safety: Elimination of risk for user and professional. | "built in feature to eliminate any risk" |
| Safety: Automatic shut-off after a specified period. | "light automatically shuts off after a specified period of time" |
| Safety: No need for safety glasses for patient/professional. | "light source in placed inside the mouth, so there is no need for safety glasses" |
| Effectiveness: Activates whitening gel to bleach teeth. | "activates the whitening gel to bleach the teeth" |
| Equivalence: Similar intended use to predicate devices. | "same intended use" |
| Equivalence: Similar functional/performance characteristics. | "similar functional and performance characteristics" |
| Equivalence: No new safety or efficacy issues raised. | "does not raise any new safety or efficacy issues" |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document does not describe a test set used for performance validation in a clinical study format. The clearance is based on comparison to predicate devices' established safety and effectiveness.
- Data Provenance: Not applicable. No specific performance data from a new study is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set with expert-established ground truth.
4. Adjudication method for the test set:
- Not applicable. No test set requiring expert adjudication is described.
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 device is a tooth whitening system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (light source), not a software algorithm.
7. The type of ground truth used:
- Not applicable in the context of a performance study. The "ground truth" for regulatory clearance is the established performance and safety of the predicate devices. The claim of "substantial equivalence" implies that the new device meets the same standards as the legally marketed predicates.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve machine learning or a training set.
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FDA 510K Summary of Safety and Effectiveness for BriteWhite Teeth Whitening System Professional
1. General Information
| Submitter: | BEKS Incorporate401 14th Avenue NE Unit #2Jasper, AL 35501888-582-3650205-384-3940 Fax |
|---|---|
| Contact Person: | Jill CreasyJC Consulting694 Bluff St. #104Carol Stream, IL 60188630-480-0476jcconsulting@comcast.net |
| Summary Preparation Date: | December 3, 2006 |
FEB 20 2007
- Device Name
| Proprietary Name: | Brite White Teeth Whitening System (Professional) |
|---|---|
| Classification Name: | Light source for bleaching teeth (21 CFR 872.6475). |
3. Predicate Device
The BriteWhite Teeth Whitening System Professional is substantially equivalent in respect to the intended use, design and method of operation to numerous cleared devices, including; the South Beach Smile Light Whitening System (K042153), QuickSmile (K052040).
4. Device Description
The BriteWhite Teeth Whitening System device that utilizes Light Emitting Diodes to provide a tooth whitening system, the whitening light source is a mouth piece which is placed inside the mouth, using barrier sleeves, which emits a biologically safe and effective level of blue visible light. The general wavelength for the mouth piece is 400 nanometer spectrums to provide a selected wavelength which activates the whitening gel to bleach the teeth without the aide of heat. To ensure user safety when operating the light, the system has a built in feature to eliminate any risk for the end user and professional. The light automatically shuts off after a specified period of time. Secondly, the light source in placed inside the mouth, so there is no need for safety glasses for the patient and professional. No contact with the eyes is in this area of treatment and prevents penetrations of blue wavelength and protects the vision of the patient and professional.
ડ. Indications for Use:
-
- The BriteWhite Teeth Whitening System is intended to emit light in the 400 nanometer spectrums to provide a light source for bleaching of teeth.
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Technical Characteristics 6.
The BriteWhite Teeth Whitening System and the aforementioned predicate devices are the light source for bleaching teeth as defined in 21 CFR 898.6475.
The BriteWhite Teeth Whitening System is an economical tooth whitening light which in conjunction with the whitening gel and tooth whitening preconditioning mouth wash provides a light source for bleaching the teeth. The BriteWhite Teeth Whitening System has similar intended use and technological characteristics to the predicate devices. The primary difference is the BriteWhite Teeth Whitening System uses an inside the mouth, hand piece.
7. Conclusions
The BEKS Inc. BriteWhite Teeth Whitening System has the same intended use, with similar functional and performance characteristics. The BEKS Inc. Brite White Teeth Whitening System performs as intended and does not raise any new safety or efficacy issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The eagle is composed of thick, black lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BEKS Incorporated C/O Ms. Jill Creasy JC Consulting 694 Bluff Street, #104 Carol Stream, Illinois 60188
FEB 2 0 2007
Re: K063704
Trade/Device Name: BriteWhite Teeth Whitening System Regulation Number: 21 CFR 872.6475 Regulation Name: Heat Source for Bleaching Teeth Regulatory Class: I Product Code: EEG Dated: February 05, 2007 Received: February 05, 2007
Dear Ms. Creasy:
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 - Ms. Jill Creasy
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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clor
Chiu S. Lin, PhD 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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Indications for Use
510(k) Number (if known): K063704
Device Name: BriteWhite Teeth Whitening System
Indications for Use:
BriteWhite Teeth Whitening System is intended to emit light in the 400 nanometer spectrum to provide a light source for the bleaching of teeth.
Prescription Use × (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 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 Punse
Division Sign-Off
510(k) Number: K063704 Page 1 of 1
§ 872.6475 Heat source for bleaching teeth.
(a)
Identification. A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.(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.