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510(k) Data Aggregation
(172 days)
SciPharm's DFV Desensitizing Varnish is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
SciPharm's DFV Desensitizing Varnish is a device that consists of a synthetic compound from a natural rosin that is intended to coat a prepared tooth cavity prior to the insertion of a restorative material by forming a film that facilitates occlusion of compromised surfaces, including open dentinal tubules. DFV Desensitizing Varnish and the predicate device consist of a viscous liquid that can be applied to the teeth using a brush or similar applicator. The purpose of the 5% sodium fluoride as the source of fluoride ions for the formation of calcium fluoride, and along with the rosin, occludes the dentin tubules. Both use denatured alcohol (ethanol) as a significant component, providing fluidity for application and to promote quick drying on the tooth surface.
SciPharm's DFV Desensitizing Varnish is a topically applied, flavored (Strawberry, Bubblegum, Spearmint, Chocolate, and Marshmallow) topical varnish containing sodium fluoride on a synthetic rosin based preparation from a natural rosin. Only a professional clinician may apply DFV Desensitizing Varnish. The varnish and applicator are packaged in a thermoformed PET/PVC opaque unit dose tray, and sealed with foil.
The provided document is a 510(k) summary for a medical device called DFV Desensitizing Varnish. It details the device's properties, intended use, and comparison to predicate devices, including performance data.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria & Reported Device Performance
The document does not explicitly state "acceptance criteria" in a pass/fail sense with numerical thresholds for performance. Instead, it presents a comparison of the proposed device (DFV Desensitizing Varnish) with an "Equivalent Varnish" (presumably a predicate device or a similar product used for internal comparison) across several physical and chemical tests. The implicit acceptance criteria are that the DFV Desensitizing Varnish should perform comparably or better than the equivalent device.
| Test | Proposed DFV Desensitizing Varnish | Equivalent Varnish | Reported Device Performance (DFV) | Comments |
|---|---|---|---|---|
| Contamination | No Foreign Particles | No Foreign Particles | No Foreign Particles | Meets the comparative standard. |
| Color | Match Standard | Match Standard | Match Standard | Meets the comparative standard. Further context on what "standard" refers to is not provided, but it implies internal consistency. |
| Odor | Match Standard | Match Standard | Match Standard | Meets the comparative standard. Similar to Color, "standard" is internal. |
| Viscosity | 4500 – 6500 cps | 7000 – 8500 cps | 4500 – 6500 cps | The proposed device has a different, lower viscosity. The document does not provide context on why this difference is acceptable, but it implies it's within an acceptable range for the intended application. |
| Non-Pyrolizable % | 7.5% - 8.7% | 8.4% - 9.5% | 7.5% - 8.7% | The proposed device has a slightly lower range for non-pyrolizable percentage. Similar to viscosity, acceptability is implicit. |
| Fluoride Content | 4.5% - 5.5% NaF (2.0% - 2.5% F) | 4.5% - 5.5% NaF (2.0% - 2.5% F) | 4.5% - 5.5% NaF (2.0% - 2.5% F) | Exactly matches the equivalent varnish, which is a key performance metric for a fluoride varnish. |
| Cytotoxicity | 11% cell viability (Toxicon Report 17-04113-G1) | 11% cell viability (Toxicon Report 18-00602-G1) | 11% cell viability | Both devices showed 11% cell viability, which is below the 70% threshold. The document explains this is expected due to ingredients like ethanol and sodium fluoride, and is considered acceptable as it's consistent with existing approved varnishes. |
| Dentin Tubule Occlusion (SEM) | Smooth with minimal surface defects | Subsurface porosity and heterogeneity | Smooth with minimal surface defects | The proposed device demonstrated a "thick uniform film with fewer defects and protrusions" than the competitor's varnish, suggesting better performance in this aspect. |
| Shelf Life | Stable for at least 24 months | Not specified | Stable for at least 24 months | Demonstrated stability through internal testing (Report 2019-R-012). |
2. Sample Size Used for the Test Set and Data Provenance
- Cytotoxicity Test: Not explicitly stated for either the DFV Desensitizing Varnish or the equivalent device. It refers to "L929 cells." The provenance is not specified beyond being generated by "Toxicon Report 17-04113-G1" and "Toxicon Report 18-00602-G1."
- Dentin Tubule Occlusion (SEM): Refers to "Disk-shaped human dentine specimens." The exact number of specimens/samples is not specified. The provenance (e.g., country) is not mentioned.
- Physical Tests (Contamination, Color, Odor, Viscosity, Non-Pyrolizable %, Fluoride Content): The sample size for these tests is not specified.
- Shelf Life: Not specified, but implied to be multiple units tested over time intervals (Time 0, 6 months, 12 months, 18 months, etc.) for up to 4 years.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- No expert adjudication is mentioned or implied for these performance tests. The tests are laboratory-based and objective (e.g., cell viability percentage, SEM imaging, chemical concentration measurements).
4. Adjudication Method for the Test Set
- None. As the tests are objective laboratory measurements, there is no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This device is a cavity varnish, not an AI-powered diagnostic or assistive technology. It does not involve human readers interpreting cases or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. As above, this is not an AI-powered device. Performance is measured directly from the physical and chemical properties of the varnish.
7. The Type of Ground Truth Used
- Cytotoxicity: Measured cell viability against a control and compared to a 70% threshold (ISO 10993-5 and ISO 7405 standards).
- Dentin Tubule Occlusion (SEM): Direct microscopic observation and characterization of the film formed on dentine specimens.
- Physical/Chemical Tests: Laboratory measurements against internal "standards" or specifications (e.g., specific viscosity range, fluoride content percentage).
- Shelf Life: Stability over time judged by changes in contamination, color, viscosity, fluoride content, nonpyrolizable percentage, and odor against acceptable ranges.
8. The Sample Size for the Training Set
- Not applicable. This device is a pharmaceutical product (dental varnish), not a machine learning model, so there is no concept of a "training set" for model development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for a machine learning model, this question does not apply.
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