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.

Device Description

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.

AI/ML Overview

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.

Summary

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OCT 1 5 1998

Waggoner Product Development

7517 White Castle Ln Plano, TX 75025 (972) 618-6090 Fax: (972) 491-1324

K981565

PREMARKET NOTIFICATION 510(k) SUMMARY SAFETY AND EFFECTIVNESS

In response to the requirements addressed under section 513 (I)(3)(A) of the Act, I am enclosing a summary of the safety and effectiveness information upon which SUBSTANTIAL EQUIVALENCE determination is based.

CONTACT PERSON

Mark B. Waggoner, D.D.S. President Waggoner Product Development 7517 White Castle Ln. Plano, TX 75025 (972) 618-6090 Fax: (972) 491-1324

CLASSIFICATION NAME: Dental Operative Unit and Accessories ( per 21 CFR section 872.6640) Dental Operative Unit Waterline Disinfectant COMMON NAME: BioClear Concentrate PROPRIATORY NAME: Dental Operative Unit Waterline Disinfectant

CLASS: 1

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SUBSTANTIAL EQUIVALENCE

BioClear Concentrate is similar in its intended use and mode of action to the Dentosept I disinfectant, legally marketed by both Pelton & Crane Company, Charlotte, N.C. with their Spirit 1/ 2, K962071 and Siemens Company, Germany, with their Sirona Water Purification Unit, K901672.

However, we feel that BioClear Concentrate is superior to Dentosept P. relative to its technological characteristics, its clinical performance and its safety.

DESCRIPTION OF DEVICE

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INTENDED USE OF DEVICE

I .ike Dentosept P, BioClear Concentrate is a dental operative unit waterline disinfectant. Both products are diluted ( BioClear == 71.4water/1 BioClear and Dentosept P = 100 water/1 Dentosept P) in tap water ( Dentosept P requires naturally or artificially softened water). This diluted mixture of either disinfectant is placed in an independent water reservoir system which supplies the dental operative unit. Thus, both disinfectants are constantly present in the waterlines and in the water delivered to the patient. Both disinfectants have been shown, in limited clinical and laboratory studies, to destroy the viability of the waterline bacterial biofilms tested ( Dentosept P must not be diluted to accomplish this endpoint). Both of these disinfectants have also been shown, in clinical and laboratory studies, to kill several typical water borne bacteria (Dentosept P, in its diluted form is minimally effective against Pseudomonas). Dentosent P requires periodic "sanitizing treatment cycles". BioClear Concentrate, properly diluted (even in hard water) does not require special treatment cycles and can be left stagmant for one month without a loss of effectiveness.

TECHNOLOGICAL CHARACTERISTICS

Both properly diluted BioClear Concentrate and Dentosept P have been shown, in both limited clinical and laboratory studies, to destroy the viability of waterline bacterial biofilms tested. Dentosept P must be applied full strength to the dental operative unit waterlines for 24 hours, as a "sanitizing treatment cycle", to be effective. In testing, BioClear Concentrate was shown to destroy the viability of mature biofilms, at its diluted concentration, in 7 days of constant contact. 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, Because of documented re-contamination with diluted Dentosept P, this 24 hour sanitizing treatment cycle must be repeated periodically throughout the yea relative to bacterial testing results.

BioClear's superiority also relates to its ability to produce 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. The

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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 Variations in rate of kill were linked to the free chlorine levels found in the tap water. Kill rates for Stanhylococcus aureus were 1 hour. This relates to BioClear's mechanism of action. Gram negative bacteria represent the vast majority of water originated bacteria.

Dentosept P's potential for biofilm regrowth relates to its inability to effectively kill Gram negative bacteria in time-kill experiments. Particularly alarming was the continued growth, after 72 hours in contact with the diluted Dentosept P. of Pseudomonas, This information is found in Attachment G. Predicate Device Information.

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. This attribute allows the dentist to return to work after a vacation, and begin their practice immediately. BioClear Concentrate, after being utilized for at least 2 weeks, appears to offer the dental operative unit waterlines a bacteriostatic potential for up to 3 week into the future. This means that if a practitioner runs out of BioClear Concentrate for a week or two. their waterlines have been shown to still inhibit bacterial growth. If they utilize sterile water, they have been shown to deliver no bacteria, and if they utilize tap water, they have been shown to deliver water with contamination levels at the same or one log higher levels. This offers a "safety net" to the practitioner and patient should this occur. If Dentosent P treated water is left stagnant in the dental unit waterlines for a week, the dental unit waterlines must have a 24 hour sanitizing treatment cvcle performed to bring the bacterial levels under control.

At a pH of 1.42, the BioClear Concentrate is bacteriocidal, and yeast-cidal. Some molds, like Aspergillus niger which can produce cittic acid, are resistant to very low pH levels. Thus, sodium benzoate (a GRAS chemical which is utilized in the beverage industry to inhibit molds and yeasts) has been added at a percentage of 0.25% to eliminate the mold contamination potential ( this is 7 times greater than the appropriate mycostatic dose at this pH). Repeated mold kill was seen at only 0.1%.

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் இந்து உட்படுத்துறையும் கு

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MECHANISM OF ACTION

The active agent in BioClear Concentrate is Citric Acid, while the active agents in Dentosept P are hydrogen peroxide and elemental silver. Citric acid functions as a chelator of divalent ions like Mg+ and Ca++ which bind certain cell wall constituents to the cell wall of Gram negative bacteria. Once the cell wall in compromised, it allows for easy ingress of hypochlorous acid and citric acid as well as allowing for osmotic disruption of the bacterial cell wall and membraue. The second mechanism involves the disruption of bacterial cellular function by chelating out essential ions for enzymatic function. The third mechanism is that of an acid. Citric acid's last pKa is 3.1, at which point 1/2 of the citric acid is in its associated form. Properly diluted BioClear Concentrate has a pH of around 2.82. It is well accepted that an acid, in its associated form, can penetrate the cell wall and membrane and kill the bacteria. The final mechanism relates to the free chlorine found in tap water. Below a pH of 4.1, almost 100% of the free chlorine present will be in the hypochlorous acid form, which is 80 times more gennicidal than the hypochlorite ion form. Citric acid was found to be effective with water hardness levels up to 400 ppm CaCO3 and free chlorine levels as low as 0,0 DDIN.

BioClear concentrate treated dental operative units also appear to posses a bacteriostatic potential into the future, even when only non-treated tap water is present, for up to 3 weeks. The bacteriostatic potential that citric acid offers to dental unit waterlines appears to be related to its binding to the tubing lumen.

Dentosept P utilizes hydrogen peroxide and elemental silver as its active agents. The literature states that hydrogen peroxide functions primarily by the production of hydroxyl radicals, which brings about oxidation of critical systems. Further studies have shown that hydrogen peroxide's effects are 80% reversed by 10mM of Mg+, especially when the percentage of hydrogen peroxide is below 0.1%. Diluted Dentosept P has only 0.0141% hydrogen peroxide. This could be why soft water is required when using Dentosept P. Elemental silver is apparently a bacteriostatic agent and not truly a bacteriocidal agent.

いついては、とに確定はしたり

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SAFETY

BioClear is made from the active ingredient, Citric Acid, which is a "Generally Recognized as Safe" chemical by the FDA. To this is added other food grade GRAS chemicals like sucrose, aspartame, FD & C Blue #1 and sodium benzoate ( at a final diluted concentration of only 0.0035%) . The final diluted citric acid concentration is only 0.224%, which is slightly more concentrated than 7-up® (0.144%) and much less concentrated than lemonade ( 1.0 -1.1%).

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. For the first week. Zinc levels were higher ( 0.750 mg/ 0.522 mg in the overnight 16ml draw) but these levels dropped to non-detectable levels on the third and fifth week because the surface atoms had been oxidized/ chelated out. Trace metals were found to reach their highest levels ( still considered to be non-detectable) after being left stagnant overnight. Flushing the lines for about 15- 30 seconds was found to reduce the trace metals to levels below the source water content for the first 3 weeks. After this three week period. the flushing cycles appears to offer virtually no difference. Dental plastics and rubbers are resistant to high concentrations of citric acid.

Dentosept P is made from hydrogen peroxide diluted to 0,0141%, and elemental silver, diluted to 0.25 mg/liter ( 0.25 ppm). Although the hydrogen peroxide is probably safe in its diluted form, elemental silver raises questions. Only 5 rats were fed Dentosept P for one week for the toxic effect study. No log term heavy metal analysis was performed, and no study was performed relative to oral tattooing, argyria, on dental patients,

SUMMARY

Because of its intended use, as a dental waterline disinfectant agent, and its mode of action, as an agent constantly present in the dental operative unit waterlines, we feel that BioClear Concentrate is substantially equivalent to Dentosept P. We also feel that duc to the technological characteristics, mechanism of action and well documented safety, BioClear Concentrate is substantially equivalent or an improvement over the comparative legally marketed Dentosept P.

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Image /page/6/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

OCT 1 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mark B. Waggoner, B.S., D.D.S. Waqqoner Product Development 7517 White Castle Lane Plano, Texas 75025

Re : K981565 Trade Name: BioClear Concentrate Requlatory Class: I Product Code: EIA Dated: July 21, 1998 Received: July 20, 1998

Dear Dr. Waggoner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Waggoner

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Timothy A. Ulatowski

Timothy A. Ulatowsk Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 42 of

K981565 510(k) Number (if known):

BioClear Concentrate Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruoees

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number

Prescription Use √
(Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Form:

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.