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510(k) Data Aggregation
(167 days)
BioClear Concentrate is intended to be diluted daily into tap water and placed in an independent dental reservoir bottle system, which would act as the sole supply of water for the Dental Operative Unit. There, the diluted BioClear Concentrate would act as a constantly present, potable, antimicrobial agent. It has been found to aid in the control of the microbial population in dental unit waterlines.
The BioClear Concentrate is intended to be added to an independent water supply system reservoir bottle and would act as a constantly present disinfectant agent in the dental operative unit. It has been found to aid in the control of the microbial population in dental unit waterlines. A number of independent water systems can be purchased separately and retrofitted to a pre-existing dental operative unit or can easily be found included on a large number of newer dental operative units and are often referred to as a "clean water" systems. The BioClear Concentrate is composed of 16% Citric Acid. U.S.P./F.C.C. as the only active ingredient. Other GRAS chemicals, 14.3% glucose F.C.C., 0.8% Aspartame F.C.C., and 0.25% Sodium Benzoate F.C.C. ( which only acts as a preservative for the concentrate), and 0,008% FD & C Blue #1, The artificial and natural sweeteners are added only to offer an agreeable flavor. The blue color is added to ensure the BioClear Concentrate has, in fact, been added to the tap water. The BioClear Concentrate would be mixed with tap water in a ratio of 7 ml/ 500 ml +/-0.5ml to produce a final concentration of 0.224% citric acid, and would be changed daily. The dental operative unit should be purged/ flushed for 15 seconds every morning for the first 3 weeks. After this period of time, although recommended, it makes virtually no difference. All of these chemicals are Generally Recognized as Safe (GRAS) as per the FDA.
Here's an analysis of the provided text regarding the BioClear Concentrate device, focusing on acceptance criteria and supporting studies:
BioClear Concentrate: Acceptance Criteria and Supporting Study Analysis
The provided 510(k) summary for BioClear Concentrate primarily focuses on demonstrating substantial equivalence to a predicate device (Dentosept P) based on intended use, technological characteristics, and safety. While direct "acceptance criteria" as clear quantitative thresholds are not explicitly stated, the document details performance claims and provides evidence from various studies to support these claims.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Microbial Control in Dental Unit Waterlines | Aid in the control of the microbial population in dental unit waterlines. |
| Biofilm Destruction (Mature biofilms) | Destroyed viability of mature biofilms at diluted concentration in 7 days of constant contact. Eliminated all biofilm matrix from tubing samples (scanning electron microscopy). |
| Bacterial Kill (Planktonic and Biofilm Bacteria) | Produced 7 log reductions of all planktonic and biofilm bacteria tested (ATCC and wild type) at 89% of recommended concentration. |
| Rapid Kill (Specific ATCC Bacteria) | Mean 5 log reduction in 10 minutes for ATCC Pseudomonas aeruginosa, ATCC Escherichia coli, and ATCC Klebsiella pneumoniae. |
| Kill Rate for Staphylococcus aureus | 1 hour kill time for Staphylococcus aureus. |
| Effectiveness During Stagnation | In a dental school clinical study, no bacterial growth detectable after 4 weeks of stagnation when utilizing properly diluted BioClear Concentrate. Offers bacteriostatic potential for up to 3 weeks into the future even if use is ceased. |
| Fungicidal/Yeast-cidal Activity | Bacteriocidal and yeast-cidal at pH 1.42. Sodium Benzoate (0.25%) added to eliminate mold contamination potential (7x greater than appropriate mycostatic dose; repeated mold kill seen at 0.1%). |
| Trace Metal Levels in Treated Water | Metal analysis showed no trace metals reaching health or equipment destruction hazard levels. Initial zinc levels (first week) dropped to non-detectable levels in weeks 3 and 5. Flushing reduced trace metals to below source water content for the first 3 weeks. |
| Compatibility with Dental Materials | Dental plastics and rubbers are resistant to high concentrations of citric acid. |
| Safety (Active Ingredient, Byproducts, Excipients) | Active ingredient (Citric Acid) is GRAS. All other chemicals (glucose, aspartame, sodium benzoate, FD&C Blue #1) are GRAS. Diluted citric acid concentration (0.224%) is comparable to beverages. No trace metals reached hazardous levels. |
| Does not require special treatment cycles/softened water | Does not require special treatment cycles (unlike predicate). Effective even in hard water. |
| Long-term effectiveness during stagnation (without re-dose) | Can be left stagnant for one month without loss of effectiveness. Offers bacteriostatic potential for up to 3 weeks even if BioClear Concentrate runs out (after 2 weeks of prior use), allowing for tap water use with only same or one log higher contamination levels. Avoids need for 24-hour sanitizing treatment cycle for stagnant water (unlike predicate). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly define a single "test set" with a specified sample size for all performance claims. Instead, it refers to various studies:
- Biofilm Destruction: "In testing, BioClear Concentrate was shown to destroy the viability of mature biofilms..." (No sample size specified).
- Biofilm Matrix Elimination: "BioClear has been further shown, in a laboratory study and a dental school clinical study, to eliminate all the biofilm matrix from the tubing samples examined by scanning electron microscopy, of a wel established biofilm, with disruption seen as early as one week..." (No sample size for tubing samples specified).
- Bacterial Log Reductions (Planktonic/Biofilm): "7 log reductions all planktonic bacteria as well as biofilm bacteria tested ( both ATCC and wild type) when tested at only 89% of its recommended concentration." (No sample size for bacterial strains or tests specified).
- Time Kill Capabilities (Rapid Kill): "time kill capabilities of BioClear are most keenly exemplified by its ability for very rapid kill ( 10 minute, mean 5 log reduction) of the ATCC Pseudomonas acruginosa. ATCC Escherichia coli, and ATCC Klebstella pneumonta." (Implies multiple tests for each strain, but no specific N mentioned).
- Stagnation Study: "In a dental school clinical study, dental units utilizing properly diluted BioClear Concentrate were shown to have no bacterial growth detectable after being left stagnant for 4 weeks." (No specific number of dental units mentioned).
- Trace Metal Analysis: "Metal analysis of the treated water showed that no trace metals were found to reach levels which would pose a health hazard or an equipment destruction hazard." (No sample size for water samples or units specified).
Data Provenance:
- Laboratory studies: Used for biofilm matrix elimination, bacterial log reductions, and time-kill capabilities.
- Dental school clinical study: Used for biofilm matrix elimination and the stagnation study.
- Ad-hoc "testing" and "metal analysis": Mentioned without specific study types.
The country of origin is not explicitly stated for these studies, but the overall submission is from a US company (Waggoner Product Development, Plano, TX).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not describe the use of independent experts to establish ground truth in the context of a "test set" for performance evaluation, as one might see in diagnostic device studies. The performance claims are results of laboratory and clinical studies. Therefore, parameters like "number of experts" or "qualifications" for ground truth establishment are not applicable in the way they would be for image- or clinical-data-based evaluations. The "ground truth" here is derived from microbiological assays and analytical chemistry.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a ground truth adjudication process involving multiple human evaluators or a consensus method described for the microbiological or chemical tests conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study, which typically evaluates human reader performance with and without AI assistance, was not conducted. This type of study is not relevant for a disinfectant product's performance evaluation.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense. The various laboratory and clinical studies described represent the "standalone" performance of the BioClear Concentrate disinfectant without human intervention in its action (beyond proper dilution and application). The reported performance results (e.g., log reductions, biofilm elimination, stagnation effectiveness) are inherent properties of the product itself.
7. The Type of Ground Truth Used
The ground truth used for evaluating BioClear Concentrate's performance is based on microbiological assays (e.g., measuring bacterial growth, viability, log reductions, biofilm presence) and analytical chemistry (e.g., trace metal analysis, chemical composition). For instance, "no bacterial growth detectable" is a direct microbiological measurement.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical disinfectant, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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