(4 days)
The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Material to protect soft tissues during teeth-whitening procedures.
The BriteSmile Masking Cream protects the lips and mucosal areas farther away from the teeth that will not come into contact with the teeth whitening gel but which may be exposed to heat from the BriteSmile lamp used to activate the bleaching gel during the teeth whitening procedure. The BriteSmile Masking Cream is a white cream with a pH of 6.5 to 7.0.
The provided 510(k) summary for BriteSmile Masking Cream focuses on establishing substantial equivalence to a predicate device through various tests rather than setting specific acceptance criteria with performance metrics. Therefore, explicit "acceptance criteria" in the format of a performance table are not available in the document.
The document highlights the types of studies conducted to demonstrate safety and performance but does not provide quantitative results or detailed methodologies that would typically be associated with performance acceptance criteria for a medical device that produces a measurable output (e.g., diagnostic accuracy, sensitivity, specificity).
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | "Testing completed in conformance with established design control procedures to validate the safety and performance..." Implied to have met relevant biocompatibility standards. |
| Functionality | "Testing completed in conformance with established design control procedures to validate the safety and performance..." Implied to have met functional requirements (e.g., effective heat reduction). |
| Shelf Life | "Testing completed in conformance with established design control procedures to validate the safety and performance..." Implied to have met specified shelf-life requirements. |
| Antimicrobial Properties | "Testing completed in conformance with established design control procedures to validate the safety and performance..." Implied to have demonstrated appropriate antimicrobial characteristics. |
Missing Information: The document does not specify quantitative acceptance criteria (e.g., "biocompatibility shall meet ISO 10993 cytotoxicity limits") nor does it provide quantitative performance results (e.g., "cytotoxicity score of X"). It only states that testing was completed to validate safety and performance.
2. Sample Size for the Test Set and Data Provenance:
The document does not specify the sample sizes used for any of the tests (biocompatibility, functionality, shelf life, antimicrobial). It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). Dental product studies often involve human subject testing or in vitro/ex vivo testing, but no details are provided here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided. The product is a masking cream, and its performance is evaluated through technical and biological tests rather than interpretation or diagnosis by experts.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. The nature of the studies (biocompatibility, functionality, etc.) does not typically involve adjudication like in diagnostic imaging studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret results, which is not the case for a masking cream.
6. Standalone (Algorithm Only) Performance Study:
No standalone performance study in the context of an algorithm or AI was conducted or mentioned. The device is a physical product (masking cream), not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the tests mentioned (biocompatibility, functionality, shelf life, antimicrobial) would be established by:
- Biocompatibility: Adherence to established biocompatibility standards (e.g., ISO 10993 series) and specific test results (e.g., non-cytotoxic, non-irritating).
- Functionality: Demonstrating the ability to reduce heat transmission and protect soft tissue as intended. This might involve thermal measurements or clinical observations.
- Shelf Life: Stability testing to ensure the product maintains its properties over its declared shelf life.
- Antimicrobial: Standard microbiological testing to evaluate antimicrobial efficacy or resistance to microbial growth.
The document does not detail the specific methodology for establishing these "ground truths."
8. Sample Size for the Training Set:
This information is not applicable and not provided. The device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided, as there is no training set for this type of device.
Summary of Available Information:
The 510(k) summary for BriteSmile Masking Cream emphasizes that safety and performance were validated through standard design control procedures, including biocompatibility, functionality, shelf life, and antimicrobial testing. However, it does not provide specific quantitative acceptance criteria or detailed results of these tests. The nature of the device (a masking cream) means that many of the requested categories related to expert interpretation, AI, or diagnostic performance are not applicable.
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APR - 2 2004
510(k) Summary for BriteSmile Masking Cream
1. SPONSOR
BriteSmile, Inc. 490 Wiget Lane Walnut Creek, CA 94598
Contact Person: Steven Miller Telephone: 925-941-6260
Date Prepared: March 26, 2004
2. DEVICE NAME
Proprietary Name: BriteSmile Masking Cream Common/Usual Name: Gingival isolation material Classification Name: Rubber Dam
3. PREDICATE DEVICE
BriteSmile Barrier Material, K010935
4. INTENDED USE
The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Matcrial to protect soft tissue during teeth-whitening procedures.
ડ. DEVICE DESCRIPTION
The BriteSmile Masking Cream protects the lips and mucosal areas farther away from the teeth that will not come into contact with the teeth whitening gel but which may be exposed to heat from the BriteSmile lamp used to activate the bleaching gel during the teeth whitening procedure. The BriteSmile Masking Cream is a white cream with a pH of 6.5 to 7.0.
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ર્દ્ર -BASIS FOR SUBSTANTIAL EQUIVALENCE
The BriteSmile Masking Cream is intended to be used with and has the same intended use as the BriteSmile Barrier Material. The Barrier Material protects the gingival areas adjacent to the teeth from the bleaching agent, a neutral pH, 15% hydrogen peroxide gel, and the masking cream reduces the transmission of heat gencrated by the BriteSmile Whitening lamp through to the soft tissue, thus maintaining patient comfort during the whitening procedure. Testing completed in conformance with established design control procedures to validate the safety and performance of the Masking Cream included biocompatibility, functionality, shelf life, and antimicrobial testing.
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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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2004
BriteSmile, Incorporated C/O Ms. Sheila Hemeon-Heyer, JD, RAC Director of Regulatory Services Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K040797
Trade/Device Name: BriteSmile Masking Cream Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Codes: EIE and EEG Dated: March 26, 2004 Received: March 29, 2004
Dear Ms. Hemeon-Heyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave re revea your December in the device is substantially equivalent (for the indications for relected in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreated of the Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic nuve been toolabilited in an and 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 may of subjoct to been as 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. Sheila Hemeon-Heyer, JD, RAC
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) I mis lower will and a your finding of substantial equivalence of your device to a legally premaince nodicate 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 rryou decire of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR please note in regarantin. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Susan Runnir
E. 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):
K040-997
Device Name: BriteSmile Masking Cream
Indications for Use:
The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Material to protect soft tissues during teeth-whitening procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/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 Fvaluation (ODE)
Swaluny
Division Sign-Off Division of Anesthesiology, General Hospital. Intection Control. Dental D
510(k) Number: K040797
§ 872.6300 Rubber dam and accessories.
(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(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 § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.