(167 days)
Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
Profisil® Fluoride Varnish is designed to securely adhere to the tooth surface for several hours while releasing fluoride ions. The varnish contains 5 % sodium fluoride suspended in a mucosa-friendly, pleasantly flavored dimethicone gel. The varnish is available in following versions: mint, berry and unflavored.
The provided document describes a 510(k) premarket notification for a dental device, "Profisil Fluoride Varnish." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for effectiveness. Therefore, the information typically requested about acceptance criteria and studies proving a device meets them for new effectiveness claims, especially those involving AI or comparative effectiveness with human readers, is not directly applicable to this specific submission.
However, the document does detail how the new device demonstrates equivalence to its predicate, focusing on non-clinical performance and biocompatibility. Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
For "Profisil® Fluoride Varnish," the acceptance criteria for non-clinical performance are based on the international standard EN ISO 17730:2020 "Dentistry - fluoride varnishes."
| Performance Characteristic | Acceptance Criteria (EN ISO 17730:2020) | Reported Device Performance (Profisil® Fluoride Varnish) | Conclusion |
|---|---|---|---|
| pH value | Not explicitly stated, but within standard requirements | Assessed and verified against EN ISO 17730:2020 | Fulfilled |
| Dynamic viscosity | Not explicitly stated, but within standard requirements | Assessed and verified against EN ISO 17730:2020 | Fulfilled |
| Fluoride release | Not explicitly stated, but within standard requirements | Assessed and verified against EN ISO 17730:2020 | Fulfilled; equivalent rate to predicate |
| Electron microscopy (SEM) study | Not explicitly stated, but within standard requirements | Assessed and verified against EN ISO 17730:2020 | Fulfilled |
| Total Fluoride | Relevant for functioning as intended (EN ISO 17730:2020) | Contains 5% sodium fluoride (identical to predicate) | Equivalent |
Biocompatibility Acceptance Criteria:
| Test | Standard | Acceptance Criteria | Reported Device Performance (Profisil® Fluoride Varnish) |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | Meets ISO 10993-5 requirements | Met requirements |
| Sensitization | ISO 10993-10 | Meets ISO 10993-10 requirements | Met requirements |
| Irritation | ISO 10993-23 | Meets ISO 10993-23 requirements | Met requirements |
| Pyrogenicity | ISO 10993-11 | Meets ISO 10993-11 requirements | Met requirements |
| Systemic toxicity | ISO 10993-11 | Meets ISO 10993-11 requirements | Met requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Test set sample size: Not explicitly stated as this is a non-clinical device evaluation. The "test set" would refer to the samples of the Profisil® Fluoride Varnish subjected to the various physical and chemical tests (e.g., specific batches for pH, viscosity, fluoride release tests) and biocompatibility studies (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation). The exact number of samples tested for each property is not detailed in the summary.
- Data provenance: The standard EN ISO 17730:2020 is an international standard. Biocompatibility standards like ISO 10993 series are also international. The summary indicates these tests were performed to demonstrate compliance with these standards, suggesting laboratory testing specifically for the Profisil® product. There is no information on country of origin of data beyond the manufacturer being based in Germany. The data is prospective as it was generated to support the current submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for this type of device comparison is based on established scientific and engineering principles codified in international standards (EN ISO 17730:2020 for dental fluoride varnishes) and biocompatibility standards (ISO 10993 series). The results are objectively measured physical and chemical properties and biological responses, not subjective interpretations by human experts in the sense of medical image analysis.
4. Adjudication Method for the Test Set
Not applicable, as the "test set" involves objective laboratory measurements against predefined standard requirements rather than subjective assessments requiring adjudication.
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 dental fluoride varnish, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable for the same reason as above; this is a physical dental material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the current device's performance evaluation is based on International Standards:
- EN ISO 17730:2020 "Dentistry - fluoride varnishes" for physical and chemical properties (pH, dynamic viscosity, fluoride release, SEM).
- ISO 10993 series for biocompatibility studies (cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity).
These standards define the acceptable range or nature of results for these properties, which serve as the objective "ground truth" for evaluation.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.